IBMNCT03633318
Establishing Muscle Impedance Parameters With Electrical Impedance Myography
An observational study of IBM and Inclusion Body Myositis, run by Yale University at 1 site in United States.
Trial summary
The primary aim of this study is to assess the changes in the impedance parameters of muscles in inclusion body myositis (IBM) through electrical impedance myography (EIM), an emerging non-invasive electrodiagnostic technology. Read more about this study
- Who is it for?
- Ages 46 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBM, Inclusion Body Myositis
- What is being tested?
- electrical impedance myography (EIM)
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with IBM compared with age and sex matched people of typical health with: no active neuromuscular disorders or known history of neuromuscular disorders; no sign or symptoms of muscle weakness; no family history of muscular dystrophies or ALS. .
Who may be able to join
- Clinico-pathologically defined IBM in the absence of any other significant neurological problem or cognitive dysfunction.
- Healthy controls will be age and gender-matched to the enrolled IBM patients.
Who cannot join
- Patients with decompensated congestive heart failure
- Patients with chronic kidney disease on hemodialysis
- Patients with active cancer on chemotherapy or radiotherapy
- Patients with severe disease who are already wheel-chair bound
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Physicians Building
New Haven, Connecticut, 06519
About this study
Official title: Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)
The primary aim of this study is to assess the changes in the impedance parameters of muscles in inclusion body myositis (IBM) through electrical impedance myography (EIM), an emerging non-invasive electrodiagnostic technology. Muscle impedance parameters can potentially serve as an objective biomarker reflecting disease progression and severity.
Read the detailed description
In this pilot study, the electrical impedance myography (EIM) parameters of individuals with inclusion body myositis (IBM) will be compared with age and sex matched normal data. Along with EIM parameters, clinical outcome measures will be obtained to understand how EIM data correlates with these parameters. A focused study to assess muscle health in IBM patients through EIM is essential to gather further insight into the potential application of this technology as a disease biomarker. Additionally, this investigation will provide critical data for the design of a subsequent biomarker validation study.
- Conditions
- IBM, Inclusion Body Myositis
- Being tested
- electrical impedance myography (EIM)
- Keywords
- electrical impedance myography, EIM
- Medical subject headings
- Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance myography (EIM)Device
EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.
| Study group | Role | What they receive |
|---|---|---|
| IBM Group | Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles. Receives: Device: electrical impedance myography (EIM) | |
| Control Group | Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles. Receives: Device: electrical impedance myography (EIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBM-Functional Rating Scale
Physical functioning in daily life will be measured using the IBM-Functional rating scale (IBM-FRS). IBM-FRS will be obtained for both IBM participants and healthy controls.
Measured: 45 Minutes
Grip Strength
Grip strength will be assessed using the Jamar hand dynamometer and will be obtained by the physician from both IBM participants and healthy controls. The best of three attempts will be used.
Measured: 45 Minutes
Time to Stand
Time to stand will be measured using the "Get-up-and-go test". Time will be measured for a participant to stand up from a chair (using arms if necessary), walk 3 meters, turn around, return to the chair, and sit down. The better of two trials will be used. These results will be obtained by the physician from both IBM participants and healthy controls.
Measured: 45 Minutes
Walking Distance
Distance walked by a participant in 6 minutes will be measured. Given the general disability of many IBM participants, rather than utilizing two trials, a 2-minute "practice" walk will be performed before the actual test, to familiarize the participant with the task to be performed. Both IBM participants and healthy controls will undergo this procedure.
Measured: 45 Minutes
Manual Muscle Testing (MMT) Global Score
This is a hands-on assessment that will use the Medical Research Council muscle scales (MRC) to score the strength of the following muscle groups that may be involved in IBM: neck flexor, extensor, deltoid, biceps, triceps, wrist extensor, wrist flexors, finger long and short flexors, finger extensors, hip flexors, hip adductors, hip abductors, knee extensors, knee flexors, ankle dorsi and planti flexors. MRC scores will be obtained by the physician from both IBM participants and healthy controls. A global score can be calculated and will be used. 0 (none) = no contraction, 1 (trace) = visible contraction with no motion, 2 (poor) = full range of motion, gravity eliminated, 3 (fair) = full range of motion against gravity, 4 (good) = full range of motion against gravity, moderate resistance, 5 (normal) = full range of motion against gravity, maximum resistance.
Measured: 45 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start19 Jun 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBMStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhaskar Roy, MBBS, Principal investigator, Yale School of Medicine: Department of NeurologyRichard J Nowak, MD, MS, Principal investigator, Yale School of Medicine: Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633318
- Sponsor's protocol ID
- 2000023035
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)
- ClinicalTrials.gov ID
- NCT03633318
- Acronym / sponsor ID
- 2000023035
- Conditions
- IBM, Inclusion Body Myositis
- Keywords
- electrical impedance myography, EIM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to assess the changes in the impedance parameters of muscles in inclusion body myositis (IBM) through electrical impedance myography (EIM), an emerging non-invasive electrodiagnostic technology. Muscle impedance parameters can potentially serve as an objective biomarker reflecting disease progression and severity.
Detailed description
In this pilot study, the electrical impedance myography (EIM) parameters of individuals with inclusion body myositis (IBM) will be compared with age and sex matched normal data. Along with EIM parameters, clinical outcome measures will be obtained to understand how EIM data correlates with these parameters. A focused study to assess muscle health in IBM patients through EIM is essential to gather further insight into the potential application of this technology as a disease biomarker. Additionally, this investigation will provide critical data for the design of a subsequent biomarker validation study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBM Group | – | Device: electrical impedance myography (EIM)Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles. |
| Control Group | – | Device: electrical impedance myography (EIM)Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles. |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with IBM compared with age and sex matched people of typical health with: no active neuromuscular disorders or known history of neuromuscular disorders; no sign or symptoms of muscle weakness; no family history of muscular dystrophies or ALS. .
Key inclusion criteria (2 listed)
- Clinico-pathologically defined IBM in the absence of any other significant neurological problem or cognitive dysfunction.
- Healthy controls will be age and gender-matched to the enrolled IBM patients.
Key exclusion criteria (4 listed)
- Patients with decompensated congestive heart failure
- Patients with chronic kidney disease on hemodialysis
- Patients with active cancer on chemotherapy or radiotherapy
- Patients with severe disease who are already wheel-chair bound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical impedance myography (EIM)EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health. | Device | Control Group, IBM Group |
Primary outcome
IBM-Functional Rating Scale
Time frame: 45 Minutes
Physical functioning in daily life will be measured using the IBM-Functional rating scale (IBM-FRS). IBM-FRS will be obtained for both IBM participants and healthy controls.
Grip Strength
Time frame: 45 Minutes
Grip strength will be assessed using the Jamar hand dynamometer and will be obtained by the physician from both IBM participants and healthy controls. The best of three attempts will be used.
Time to Stand
Time frame: 45 Minutes
Time to stand will be measured using the "Get-up-and-go test". Time will be measured for a participant to stand up from a chair (using arms if necessary), walk 3 meters, turn around, return to the chair, and sit down. The better of two trials will be used. These results will be obtained by the physician from both IBM participants and healthy controls.
Walking Distance
Time frame: 45 Minutes
Distance walked by a participant in 6 minutes will be measured. Given the general disability of many IBM participants, rather than utilizing two trials, a 2-minute "practice" walk will be performed before the actual test, to familiarize the participant with the task to be performed. Both IBM participants and healthy controls will undergo this procedure.
Manual Muscle Testing (MMT) Global Score
Time frame: 45 Minutes
This is a hands-on assessment that will use the Medical Research Council muscle scales (MRC) to score the strength of the following muscle groups that may be involved in IBM: neck flexor, extensor, deltoid, biceps, triceps, wrist extensor, wrist flexors, finger long and short flexors, finger extensors, hip flexors, hip adductors, hip abductors, knee extensors, knee flexors, ankle dorsi and planti flexors. MRC scores will be obtained by the physician from both IBM participants and healthy controls. A global score can be calculated and will be used. 0 (none) = no contraction, 1 (trace) = visible contraction with no motion, 2 (poor) = full range of motion, gravity eliminated, 3 (fair) = full range of motion against gravity, 4 (good) = full range of motion against gravity, moderate resistance, 5 (normal) = full range of motion against gravity, maximum resistance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhaskar Roy, MBBS principal investigator
Yale School of Medicine: Department of Neurology
Richard J Nowak, MD, MS principal investigator
Yale School of Medicine: Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBM and Inclusion Body Myositis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBM-Functional Rating Scale (time frame: 45 Minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.